APIs and Excipients
Dealing with Challenging APIs
January 13, 2025
Pharmaceutical Technology chats about the increasing prevalence of challenging APIs in the development pipeline and the hurdles facing formulators and manufacturers as a result of this trend with Jens Schmidt from Lonza.
J&J Gets FDA Fast Track Designation for Alzheimer’s mAb, Posdinemab
January 09, 2025
Posdinemab is the second tau-directed investigational therapy by J&J that has received fast track designation from FDA this year for Alzheimer’s disease.
Argobio and University of Southern Denmark Launch New Next-Gen RNA Company, Inverna Therapeutics
January 08, 2025
Using splicing technology, the new company aims to innovate safer and more effective RNA therapies for severe genetic diseases.
Roche Forms Partnership Worth Potentially More than $1 Billion with Innovent to Develop Novel ADC for SCLC
January 03, 2025
Under the agreement, the companies will advance development of IBI3009, Innovent’s ADC candidate, which has received IND approvals in the US, China, and Australia.
Bispecific Antibody Development and Where It’s Headed
January 01, 2025
In a discussion on bispecific antibody development, Atul Mohindra, head of Biologics R&D at Lonza, points out the challenges and successes of these molecules as well as the field’s future direction from a CDMO perspective.
Prasinezumab Misses Primary Endpoint in Roche’s Phase IIb Study, but Has Potential in Treating Early Stage Parkinson’s Disease
December 25, 2024
Results from a Phase IIb study missed the primary endpoint by failing to achieve statistical significance.
EMA’s CHMP Gives Positive Opinion for Use of Lecanemab in Early Alzheimer’s Disease
November 16, 2024
CHMP has granted Eisai Europe and Biogen a positive opinion for the use of their monoclonal antibody therapy in treating early Alzheimer’s disease.
MD Anderson Launches Cell Therapy Institute
November 11, 2024
The new Institute for Cell Therapy Discovery and Innovation will utilize expertise to develop cell therapies for cancer, autoimmune diseases, and infections.
Oblenio Bio Created by Aditum Bio and Leads Biolabs to Develop Therapeutic Antibody for Treating Autoimmune Disorders
November 08, 2024
In the collaboration, the new company, Oblenio Bio, has been granted an exclusive option to license LBL-051, a tri-specific T-cell engager antibody, from Leads Biolabs.
Accelerating Discovery and Development with Advances in High-Throughput Screening
November 07, 2024
Automation, miniaturization, and new software algorithms are improving throughput and accuracy.